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NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01408472
First Posted: August 3, 2011
Last Update Posted: August 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey L Goldberg, Stanford University
  Purpose
Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple pre-clinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like glaucoma. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in glaucoma. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into one eye, and will be carefully followed to evaluate safety and efficacy.

Condition Intervention Phase
Glaucoma, Primary Open Angle Drug: NT-501 CNTF Implant Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CNTF Cell Implants For Glaucoma: A Phase I Study

Resource links provided by NLM:


Further study details as provided by Jeffrey L Goldberg, Stanford University:

Primary Outcome Measures:
  • Safety: Number of adverse events [ Time Frame: 18 months ]
    Safety will be evaluated by counting the number of patients with adverse events, including loss of vision, visual field, or retinal/optic nerve structure, and ocular complications such as pain and inflammation.


Secondary Outcome Measures:
  • Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; Visual Field Questionnaire-25 [ Time Frame: 18 months ]
  • Structural Efficacy: Nerve fiber layer, optic nerve topography [ Time Frame: 18 months ]

Enrollment: 11
Study Start Date: April 2011
Study Completion Date: October 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NT-501 CNTF Implant
Patients will receive single NT-501 CNTF implant in one eye.
Drug: NT-501 CNTF Implant
Single implantation of CNTF-secreting NT-501 device into one eye

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must understand and sign the informed consent
  • must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and possible removal, as well as the testing required.
  • diagnosis of glaucoma characterized by (a) clinical evidence of progressive RGC dysfunction and degeneration using both visual field and at least one structural modality; (b) residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/100; (c) failure to contain glaucomatous progression with maximally tolerated reduction of intraocular pressure (IOP), OR visual field defect affecting fixation, but not reducing BCVA below 20/100.

Exclusion Criteria:

  • other corneal, lens, optic nerve or retinal disease causing vision loss,
  • blind in one eye
  • requirement of acyclovir and/or related products during study
  • receiving systemic steroids or other immunosuppressive medications.
  • pregnant or lactating.
  • considered immunodeficient or has a known history of human immunodeficiency virus (HIV)
  • on chemotherapy, or a history of malignancy, UNLESS it was treated successfully 2 years prior to inclusion in the trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408472


Locations
United States, Florida
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
Jeffrey L Goldberg
Investigators
Principal Investigator: Jeffrey L Goldberg, MD, PhD Bascom Palmer Eye Institute, University of Miami
  More Information

Responsible Party: Jeffrey L Goldberg, Associate Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT01408472     History of Changes
Other Study ID Numbers: 20090257
First Submitted: August 2, 2011
First Posted: August 3, 2011
Last Update Posted: August 2, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases